Experts Discuss:
Composite Measures to Inform Management of Bio-naïve Patients with Psoriatic Arthritis
- 5-minute read/20-minute listen
Podcast
- Dr. Mease and Dr. Khattri • August 2023
The experts
Philip Mease, MD
Director of Rheumatology Research, Swedish Medical Center Providence St. Joseph; and Clinical Professor, University of Washington School of Medicine
Saakshi Khattri, MD
Rheumatologist and Dermatologist, Icahn School of Medicine at Mount Sinai
Key information
KEEPsAKE 1
KEEPsAKE 2
53% csDMARD-IR;
47% bDMARD-IR
ACR20 at 24 weeks was the primary endpoint in both trials
MDA at 24 weeks was a ranked secondary endpoint in KEEPsAKE 1 and 2 (NRI)1
At Week 16, subjects classified as nonresponders (defined as not achieving at least a 20% improvement in either or both TJC and SJC at both Week 12 and Week 16 compared to baseline) had the option to add or modify rescue concomitant medications/therapy.
RZB Safety from KEEPsAKE 1 and 2
TEAEs, Events (E/100 PYs) | PBO N=481, | RZB N=483, |
|---|---|---|
| TEAE | 387 (173.2) | 398 (177.6) |
| Any hepatic event | 32 (14.3) | 43 (19.2) |
| Serious AE | 22 (9.8) | 15 (6.7) |
| Any hypersensitivity | 3 (1.3) | 12 (5.4) |
| Serious infections | 8 (3.6) | 6 (2.7) |
| Injection-site reactions | 0 | 4 (1.8) |
| Herpes zoster | 1 (0.4) | 2 (0.9) |
| COVID-19-related TEAEs | 2 (0.9) | 1 (0.4) |
| Malignant tumors | 2 (0.9) | 0 |
| Malignant tumors, excluding NMSC | 2 (0.9) | 0 |
| Death | 0 | 1 (0.4)† |
| Active tuberculosis | 0 | 0 |
| MACE | 0 | 0 |
| Opportunistic infection excluding TB and HZ | 0 | 0 |
TEAEs, Events (E/100 PYs) | PBO N=219, | RZB N=224, |
|---|---|---|
| TEAE | 292 (288.3) | 286 (274.2) |
| Any hepatic event | 9 (8.9) | 11 (10.5) |
| Serious AE | 15 (14.8) | 14 (3.4) |
| Any hypersensitivity | 8 (7.9) | 6 (5.8) |
| Serious infections | 5 (4.9) | 3 (2.9) |
| Injection-site reactions | 1 (1.0) | 4 (3.8) |
| Herpes zoster | 1 (1.0) | 0 |
| COVID-19-related TEAEs | 0 | 1 (1.0) |
| Malignant tumors | 0 | 0 |
| Malignant tumors, excluding NMSC | 3 (3.0) | 1 (1.0) |
| Death | 0 | 0 |
| Active tuberculosis | 0 | 0 |
| MACE | 0 | 1 (1.0) |
| Opportunistic infection excluding TB and HZ | 0 | 0 |
TEAEs, Events (E/100 PYs) | PBO N=481, PYs=223.5 | RZB N=483, PYs=224.3 |
|---|---|---|
| TEAE | 387 (173.2) | 398 (177.6) |
| Any hepatic event | 32 (14.3) | 43 (19.2) |
| Serious AE | 22 (9.8) | 15 (6.7) |
| Any hypersensitivity | 3 (1.3) | 12 (5.4) |
| Serious infections | 8 (3.6) | 6 (2.7) |
| Injection-site reactions | 0 | 4 (1.8) |
| Herpes zoster | 1 (0.4) | 2 (0.9) |
| COVID-19-related TEAEs | 2 (0.9) | 1 (0.4) |
| Malignant tumors | 2 (0.9) | 0 |
| Malignant tumors, excluding NMSC | 2 (0.9) | 0 |
| Death | 0 | 1 (0.4)† |
| Active tuberculosis | 0 | 0 |
| MACE | 0 | 0 |
| Opportunistic infection excluding TB and HZ | 0 | 0 |
TEAEs, Events (E/100 PYs) | PBO N=219, PYs=101.3 | RZB N=224, PYs=104.3 |
|---|---|---|
| TEAE | 292 (288.3) | 286 (274.2) |
| Any hepatic event | 9 (8.9) | 11 (10.5) |
| Serious AE | 15 (14.8) | 14 (3.4) |
| Any hypersensitivity | 8 (7.9) | 6 (5.8) |
| Serious infections | 5 (4.9) | 3 (2.9) |
| Injection-site reactions | 1 (1.0) | 4 (3.8) |
| Herpes zoster | 1 (1.0) | 0 |
| COVID-19-related TEAEs | 0 | 1 (1.0) |
| Malignant tumors | 3 (3.0) | 1 (1.0) |
| Malignant tumors, excluding NMSC | 0 | 0 |
| Death | 0 | 0 |
| Active tuberculosis | 0 | 0 |
| MACE | 0 | 1 (1.0) |
| Opportunistic infection excluding TB and HZ | 0 | 0 |
The overall safety profile of RZB observed in subjects with PsA treated with RZB is generally consistent with the safety profile in subjects with plaque psoriasis, with the addition of hepatic events — for example, increased ALT and AST, but no serious hepatic events reported — and hypersensitivity reactions.
In patients treated with RZB for plaque psoriasis and PsA, the most common adverse reactions (≥1%) are upper respiratory infections, headache, fatigue, injection-site reactions, and tinea infections.
Resource
Find out more about composite measures in bio-naïve patients with PsA treated with RZB
†1 subject, 81 years of age with dementia, hospitalized for pneumonia, developed urosepsis and complications resulting in death.
ACR20, improvement of ≥20% in American College of Rheumatology core criteria; AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; bDMARD-IR, biologic disease-modifying antirheumatic drug inadequate response; COVID-19, coronavirus disease 2019; csDMARD-IR, conventional synthetic disease-modifying antirheumatic drug inadequate response; E, events; HZ, herpes zoster; IL-23, interleukin-23; MACE, major adverse cardiovascular event; MDA, minimal disease activity; NMSC, nonmelanoma skin cancer; NRI, nonresponder imputation; PBO, placebo; PsA, psoriatic arthritis; PY, person years; SJC, swollen joint count; TB, tuberculosis; TEAE, treatment-emergent adverse event; TJC, tender joint count.
Composite measures can be a valuable tool for assessing various clinical domains in patients with PsA8
How important are treatment targets in your assessment of patients with PsA?
How likely are you to use a composite measure like the MDA in monitoring a patient with PsA?
How likely are you to consider a selective IL-23 p19 inhibitor if a bio-naïve patient with PsA is not meeting treatment targets?
Indications
Risankizumab-rzaa is indicated for the treatment of active psoriatic arthritis in adults.
Risankizumab-rzaa is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Important safety considerations
Explore more posts about PsA
A Closer Look at Psoriatic Arthritis Outcome Measures and Disease Control
- Kristensen LE et al. Ann Rheum Dis. 2022;81(2):225–231.
- Östör A et al. Ann Rheum Dis. 2022;81(3):351–358.
- Kristensen LE et al. Poster presented at: American College of Rheumatology Convergence; November 10–14, 2022; Philadelphia, PA.
- Data on file, AbbVie Inc. ABVRRTI73417.
- Kristensen LE et al. Poster presented at: Fall Clinical Dermatology Conference; October 21–24, 2021; Las Vegas, NV.
- Östör A et al. Poster presented at: Fall Clinical Dermatology Conference; October 21–24, 2021; Las Vegas, NV.
- Data on file, AbbVie Inc. ABVRRTI74973.
- Mease PJ et al. Semin Arthritis Rheum. 2018;47(6):786–796.
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